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Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up

Abstract

Background

Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh.

Methods

This was a prospective, multi-institutional study of subjects undergoing retrorectus or onlay VIHR. Inclusion criteria were CDC Class I, defect 10–350 cm2, ≤ 3 prior repairs, and ≥ 1 high-risk criteria (obesity (BMI: 30–40 kg/m2), active smoker, COPD, diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, hypoalbuminemia, advanced age, and renal insufficiency). Physical exam and/or quality of life surveys were performed at regular intervals through 18 months (to date) with longer-term, 36-month follow-up ongoing.

Results

One hundred and twenty-one subjects (46M, 75F) with an age of 54.7 ± 12.0 years and BMI of 32.2 ± 4.5 kg/m2 (mean ± SD), underwent VIHR. Comorbidities included the following: obesity (n = 95, 78.5%), hypertension (n = 72, 59.5%), cardiovascular disease (n = 42, 34.7%), diabetes (n = 40, 33.1%), COPD (n = 34, 28.1%), malignancy (n = 30, 24.8%), active smoker (n = 28, 23.1%), immunosuppression (n = 10, 8.3%), chronic corticosteroid use (n = 6, 5.0%), advanced age (n = 6, 5.0%), hypoalbuminemia (n = 3, 2.5%), and renal insufficiency (n = 1, 0.8%). Hernia types included the following: primary ventral (n = 17, 14%), primary incisional (n = 54, 45%), recurrent ventral (n = 15, 12%), and recurrent incisional hernia (n = 35, 29%). Defect and mesh size were 115.7 ± 80.6 and 580.9 ± 216.1 cm2 (mean ± SD), respectively. Repair types included the following: retrorectus (n = 43, 36%), retrorectus with additional myofascial release (n = 45, 37%), onlay (n = 24, 20%), and onlay with additional myofascial release (n = 8, 7%). 95 (79%) subjects completed 18-month follow-up to date. Postoperative wound infection, seroma requiring intervention, and hernia recurrence occurred in 11 (9%), 7 (6%), and 11 (9%) subjects, respectively.

Conclusions

High-risk VIHR with P4HB mesh demonstrated positive outcomes and low incidence of hernia recurrence at 18 months. Longer-term 36-month follow-up is ongoing.

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Funding

This study was sponsored by C. R. Bard, Inc. (Davol), Warwick, RI.

Author information

Correspondence to John Scott Roth.

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Disclosures

Authors were reimbursed for expenses related to the conduct of the study. JSR, GJA, JGB, WWH, RGM, MIG, DBE, GJM, JAG, EPD, BJS, CRD, and GRV are paid consultants for C. R. Bard, Inc. (Davol). Poulose conflicts: Bard-Davol-research (pertains to this study); Americas Hernia Society Quality Collaborative-compensation; Ariste Medical-consulting; Pfizer-consulting. Deeken conflicts: Covalent Bio, LLC – Owner and Principal Consultant; Biom'Up – consulting; Colorado Therapeutics – consulting; C. R. Bard/Davol, Inc. – consulting (pertains to this study); Musculoskeletal Transplant Foundation – paid Grant reviewer; Johnson & Johnson Medical GmbH – consulting; TELA Bio, Inc. – consulting.

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Roth, J.S., Anthone, G.J., Selzer, D.J. et al. Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up. Surg Endosc 32, 1929–1936 (2018). https://doi.org/10.1007/s00464-017-5886-1

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Keywords

  • Hernia repair
  • Recurrence
  • Infection
  • Poly-4-hydroxybutyrate
  • Mesh
  • Seroma